Drug Safety

, Volume 37, Issue 4, pp 269–282 | Cite as

Thromboembolic Events in Women Exposed to Hormonal Contraception or Cyproterone Acetate in 2012: A Cross-Sectional Observational Study in 30 French Public Hospitals

  • Mathilde Gourbil
  • Aurélie Grandvuillemin
  • Marie-Noëlle Beyens
  • Nathalie Massy
  • Valérie Gras
  • Andréa D’Amico
  • Ghada Miremont-Salamé
  • Nadine Petitpain
  • The French Network of Regional Pharmacovigilance Centres
Original Research Article

Abstract

Background

In the context of the European reassessment of the benefit–risk balance of hormonal contraceptives, French data about thromboembolic events were requested.

Objective

The aim of this study was to determine the number of patients exposed to hormonal contraception or cyproterone acetate among hospitalized females diagnosed with a thromboembolic event in 2012, to retrospectively analyze specific risk factors of venous and arterial thromboembolism and to assess the magnitude of the under-reporting of such events to the national pharmacovigilance system.

Methods

This cross-sectional study included 15- to 49-year-old women with pulmonary embolism, venous cerebral thrombosis, ischemic stroke, or myocardial infarction, hospitalized in 2012, and identified within the computerized hospital databases of 30 French teaching hospitals.

Results

Among the 2,966 cases identified, 803 (27.1 %) patients had been exposed to a hormonal contraceptive (747) or to cyproterone acetate (56). Among these, there were 452 venous thromboembolic events (VTEs) and 351 arterial thromboembolic events (ATEs). Age ≥40 years and personal thrombophilia diagnosed after the event were the main VTE risk factors, while current smoking and age ≥40 years were the main ATE risk factors. The mean number of associated risk factors was significantly lower for VTE than for ATE (1.1 vs 2.3). The proportion of cases with no risk factors was higher for third- and fourth-generation than for first- and second-generation combined oral contraceptives. Overall, the under-reporting rate was 92.5 % (95 % CI 70.0–97.3).

Conclusion

This study highlighted the need to strengthen the knowledge of patients and health professionals about thromboembolic risk factors at the first prescription and renewal of hormonal contraceptives.

Notes

Acknowledgments

Collaborators from the French Network of Pharmacovigilance Centres:

Guillaume Drablier (Angers), Christian Riché (Brest), Marie Blanche Valnet Rabier (Besançon), Hélène Géniaux (Bordeaux), Marie Zenut (Clermont-Ferrand), Sophie Fedrizzi (Caen), Edith Schir (Grenoble), Marine Auffret (Lille), Marie Laure Laroche (Limoges), Franck Rouby (Marseille), Véronique Pinzani (Montpellier), Bernadette Baldin (Nice), Anne Lise Ruellan (Nantes), Dominique Swiegot (Nancy), Sylviane HOROWICZ (Paris), Christine Le Beller (Paris), Laure Thomas (Creteil), Bénédicte Lebrun-Vignes (Paris), Joelle Michot (Paris), Caroline Pecriaux (Paris), Malak Abou Taam (Reims), Marie-Noëlle Osmont (Rennes), Aude Lambert (Strasbourg), Isabelle Lacroix (Toulouse), Annie Pierre Jonville-Bera (Tours).

Collaborators from the Medical Record Units of the participating hospitals:

Elisabeth Lewandowski (Amiens), Nathalie Andreu (Angers), Jean Michel Cauvin (Brest), Marie-Claude Antraigue (Besançon), Aude Kostrzewa (Bordeaux), Emeline Duroy (Caen), Bruno Aublet-Cuvelier (Clermont-Ferrand) Hervé Aubé (Dijon), Jérome Fauconnier (Grenoble), Amelie Bruandet (Lille), Sandra Yonnet (Limoges), Sandrine Couray-Targe (Lyon), Vanessa Pauly (Marseille), Philippe Mailhe (Montpellier), Yves Gendreike (Nice), Nathalie Surer (Nantes), Haritina El Adssi (Nancy), Pavla Vicente (Paris), Paul Avillach (Paris), François Hemery (Creteil), Pierre Rufat (Paris), Jeanne Marty (Paris), Jerome Frenkiel (Paris), Danièle Blanc (Reims), Loetizia Froment (Rouen), Annie Fresnel (Rennes), Béatrice Trombert-Paviot (St Etienne), Hassina Lefevre (Strasbourg), Laurent Bieler (Toulouse), Florence Fourquet (Tours).

Contributorship statement

MG designed data collection tools, collected, cleaned and analyzed the data, drafted and revised the draft paper.

AG designed data collection tools, collected, cleaned and analyzed the data, drafted and revised the draft paper.

MNB collected and analyzed the data, drafted and revised the draft paper.

NM collected and analyzed the data, drafted and revised the draft paper.

VG collected and analyzed the data, drafted and revised the draft paper.

AD designed data collection tools.

GMS collected and analyzed the data, drafted and revised the draft paper.

NP initiated the collaborative project, designed data collection tools, collected, cleaned and analyzed the data, drafted and revised the draft paper.

All members of the Regional Pharmacovigilance Centres and all members of the Medical Record Units of the participating hospitals collected the data.

Funding and Conflicts of Interest

No sources of funding were used to conduct this study or prepare this manuscript. Mathilde Gourbil, Aurélie Grandvuillemin, Marie-Noëlle Beyens, Nathalie Massy, Valérie Gras, Andréa D’Amico, Ghada Miremont-Salamé and Nadine Petitpain have no conflicts of interest that are directly relevant to the content of this study.

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Copyright information

© Springer International Publishing Switzerland 2014

Authors and Affiliations

  • Mathilde Gourbil
    • 1
  • Aurélie Grandvuillemin
    • 2
  • Marie-Noëlle Beyens
    • 3
  • Nathalie Massy
    • 4
  • Valérie Gras
    • 5
  • Andréa D’Amico
    • 1
  • Ghada Miremont-Salamé
    • 6
  • Nadine Petitpain
    • 7
  • The French Network of Regional Pharmacovigilance Centres
  1. 1.Regional Pharmacovigilance CentreUniversity HospitalLyonFrance
  2. 2.Regional Pharmacovigilance CentreUniversity HospitalDijonFrance
  3. 3.Regional Pharmacovigilance CentreUniversity Hospital, Hôpital de BellevueSaint-ÉtienneFrance
  4. 4.Regional Pharmacovigilance CentreUniversity Hospital, Hôpital Charles NicolleRouenFrance
  5. 5.Regional Pharmacovigilance CentreUniversity Hospital SudAmiensFrance
  6. 6.Regional Pharmacovigilance CentreUniversity Hospital, Hôpital PellegrinBordeauxFrance
  7. 7.Regional Pharmacovigilance CentreUniversity Hospital of NancyNancyFrance

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